Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an
arrhythmia management company focused on improving the way cardiac
arrhythmias are diagnosed and treated, today reported results for
the second quarter of 2022.
Recent Updates:
- Reported revenue of $4.1 million in
the second quarter of 2022, compared to $3.7 million in the first
quarter of 2022, and $4.7 million in the same quarter last
year.
- Global mapping procedures volumes
increased 20% from the same quarter last year.
- Completed first closing of the
left-heart access portfolio sale to Medtronic, Inc. and debt
refinancing to fund strategic growth priorities on June 30,
2022.
“Our teams continued to execute our strategy in the
second quarter, as we intensify focus on utilization and procedure
volume as the key drivers of our business,” said David Roman,
President & CEO of Acutus. “We registered another quarter of
record procedure volumes with year-over-year growth worldwide.
Higher procedure volume was complemented by increased revenue share
capture within our accounts, as electrophysiologists increase
adoption of the Acutus product portfolio. In addition to positive
trends in utilization, we made significant strides to strengthen
our financial position, completing the first closing of our
left-heart access portfolio sale to Medtronic, refinancing our
debt, and implementing further cost reduction initiatives.”
Second Quarter 2022 Financial
ResultsRevenue was $4.1 million for the second quarter of
2022, compared to $4.7 million in the second quarter last year.
This decrease of $0.6 million, or 13%, was primarily attributable
to a decrease of $0.5 million in capital revenue and
$0.2 million in disposable revenue as stocking orders for
AcQMap installs declined with the decrease in new customer
accounts. Gross margin was negative 138% for the three months ended
June 30, 2022 and negative 59% for the three months ended
June 30, 2021. This decrease in gross margin was primarily
attributable to excess and obsolescence charges to inventory,
recognition of manufacturing variances, and idle capacity on
console manufacturing.
Excluding the net gain on the sale of our
left-heart access portfolio of $43.6 million, operating
expenses on a GAAP basis were $23.0 million for the second
quarter of 2022, compared with $24.5 million in the same
quarter last year. The decrease of $1.5 million was primarily
attributable to a decrease of $2.7 million related to headcount
related expenses, offset by a change in fair value of
$1.2 million for the contingent consideration related to the
acquisition of Rhythm Xience, Inc.
Net income on a GAAP basis was $5.7 million for the
second quarter of 2022 and net income per share was $0.16 on a
weighted average basic and diluted outstanding share count of 28.3
million, compared to a net loss of $28.7 million and a net
loss per share of $1.02 on a weighted average basic and diluted
outstanding share count of 28.2 million in the same period of the
prior year. Excluding amortization of acquired intangibles,
non-cash stock-based compensation expense, goodwill impairment,
gain on sale of business, debt refinancing charges, restructuring
charges, the employee retention credit benefit and changes in the
fair value of contingent consideration, the Company’s non-GAAP net
loss for the second quarter of 2022 was $26.2 million, or
$0.93 per share, compared to a net loss of $25.0 million, or
$0.89 per share in the same period of the prior year.
Total cash, cash equivalents, marketable securities
and restricted cash was $93.1 million as of June 30, 2022.
Non-GAAP Financial
MeasuresThis press release includes references to non-GAAP
net loss and non-GAAP net loss per share, which are non-GAAP
financial measures, to provide information that may assist
investors in understanding the Company’s financial results and
assessing its prospects for future performance. The Company
believes these non-GAAP financial measures are important indicators
of its operating performance because they exclude items that are
primarily non-cash accounting line items unrelated to, and may not
be indicative of, the Company’s core operating results. These
non-GAAP financial measures, as Acutus calculates them, may not
necessarily be comparable to similarly titled measures of other
companies and may not be appropriate measures for comparing the
performance of other companies relative to the Company. These
non-GAAP financial results are not intended to represent and should
not be considered to be more meaningful measures than, or
alternatives to, measures of operating performance as determined in
accordance with GAAP. Non-GAAP net loss is defined as net income
(loss) before income taxes, adjusted for stock-based compensation,
amortization of acquisition-related intangibles, acquisition
related costs, discontinued operations, asset/goodwill impairments,
changes in the fair value of contingent consideration,
restructuring charges, stock repurchases and other adjustments for
non-operating items, such as gain on sale of business, debt
financing charges, and employee retention credit benefits. To the
extent such non-GAAP financial measures are used in the future, the
Company expects to calculate them using a consistent method from
period to period. A reconciliation of the most directly comparable
GAAP financial measure to the non-GAAP financial measure has been
provided under the heading “Reconciliation of GAAP Results to
Non-GAAP Results” in the financial statement tables attached to
this press release.
Webcast and Conference Call
InformationAcutus will host a conference call to discuss
the second quarter 2022 financial results after market close on
Thursday, August 11, 2022 at 1:30 p.m. Pacific Time / 4:30 p.m.
Eastern Time. To access the live call via telephone, please
register in advance using the link:
https://register.vevent.com/register/BI91a149ee60de483ab484237f5ac7b27c.
Upon registering, each participant will receive an email
confirmation with dial-in numbers and a unique personal PIN that
can be used to join the call. The live webinar of the call may be
accessed by visiting the Events section of the Acutus investor
relations website at ir.acutusmedical.com. A replay of the webinar
will be available shortly after the conclusion of the call and will
be archived on the company’s website.
About Acutus Medical, Inc.Acutus
is an arrhythmia management company focused on improving the way
cardiac arrhythmias are diagnosed and treated. Acutus is committed
to advancing the field of electrophysiology with a unique array of
products and technologies which will enable more physicians to
treat more patients more efficiently and effectively. Through
internal product development, acquisitions and global partnerships,
Acutus has established a global sales presence delivering a broad
portfolio of highly differentiated electrophysiology products that
provide its customers with a complete solution for catheter-based
treatment of cardiac arrhythmias. Founded in 2011, Acutus is
headquartered in Carlsbad, California.
Caution Regarding Forward-Looking
StatementsThis press release includes statements that may
constitute “forward-looking” statements, usually containing the
words “believe,” “estimate,” “project,” “expect” or similar
expressions. Forward-looking statements inherently involve risks
and uncertainties that could cause actual results to differ
materially from the forward-looking statements. Factors that would
cause or contribute to such differences include, but are not
limited to, the Company’s ability to continue to manage expenses
and cash burn rate at sustainable levels, continued acceptance of
its products in the marketplace, the effect of global economic
conditions on the ability and willingness of customers to purchase
the Company’s systems and the timing of such purchases, competitive
factors, changes resulting from healthcare policy in the United
States and globally, including changes in government reimbursement
of procedures, dependence upon third-party vendors and
distributors, timing of regulatory approvals, the impact of the
coronavirus (COVID-19) pandemic and Acutus’ response to it, and
other risks discussed in the Company’s periodic and other filings
with the Securities and Exchange Commission. By making these
forward-looking statements, Acutus undertakes no obligation to
update these statements for revisions or changes after the date of
this release, except as required by law.
Investor Contact: |
Media Contact: |
Caroline Corner |
Levitate |
Westwicke ICR |
M: 260-408-5383 |
D: 415-202-5678 |
acutus@levitatenow.com |
caroline.corner@westwicke.com |
Acutus Medical,
Inc.Condensed Consolidated Balance
Sheets
(in thousands, except per share amounts) |
June 30, 2022 |
|
December 31,2021 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
46,567 |
|
|
$ |
24,071 |
|
Marketable securities, short-term |
|
42,400 |
|
|
|
76,702 |
|
Restricted cash, short-term |
|
150 |
|
|
|
150 |
|
Accounts receivable |
|
2,596 |
|
|
|
3,633 |
|
Inventory |
|
15,307 |
|
|
|
16,408 |
|
Prepaid expenses and other current assets |
|
9,030 |
|
|
|
5,326 |
|
Total current assets |
|
116,050 |
|
|
|
126,290 |
|
|
|
|
|
Marketable securities, long-term |
|
— |
|
|
|
7,120 |
|
Restricted cash, long-term |
|
4,000 |
|
|
|
— |
|
Property and equipment, net |
|
11,366 |
|
|
|
13,670 |
|
Right-of-use assets, net |
|
4,191 |
|
|
|
4,521 |
|
Intangible assets, net |
|
1,683 |
|
|
|
5,013 |
|
Goodwill |
|
— |
|
|
|
12,026 |
|
Other assets |
|
1,040 |
|
|
|
1,152 |
|
Total assets |
$ |
138,330 |
|
|
$ |
169,792 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
7,975 |
|
|
$ |
7,519 |
|
Accrued liabilities |
|
9,138 |
|
|
|
9,096 |
|
Contingent consideration, short-term |
|
1,800 |
|
|
|
1,500 |
|
Operating lease liabilities, short-term |
|
437 |
|
|
|
395 |
|
Warrant liability |
|
3,379 |
|
|
|
— |
|
Total current liabilities |
|
22,729 |
|
|
|
18,510 |
|
|
|
|
|
Operating lease liabilities, long-term |
|
4,346 |
|
|
|
4,591 |
|
Long-term debt |
|
34,199 |
|
|
|
40,415 |
|
Contingent consideration, long-term |
|
400 |
|
|
|
500 |
|
Other long-term liabilities |
|
5 |
|
|
|
50 |
|
Total liabilities |
|
61,679 |
|
|
|
64,066 |
|
|
|
|
|
Stockholders' equity |
|
|
|
Preferred stock, $0.001 par value |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value |
|
28 |
|
|
|
28 |
|
Additional paid-in capital |
|
590,429 |
|
|
|
584,613 |
|
Accumulated deficit |
|
(512,997 |
) |
|
|
(478,698 |
) |
Accumulated other comprehensive loss |
|
(809 |
) |
|
|
(217 |
) |
Total stockholders' equity |
|
76,651 |
|
|
|
105,726 |
|
Total liabilities and stockholders' equity |
$ |
138,330 |
|
|
$ |
169,792 |
|
Acutus Medical,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive Income (Loss)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
(in thousands, except share and per share amounts) |
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
(unaudited) |
|
(unaudited) |
Revenue |
$ |
4,076 |
|
|
$ |
4,709 |
|
|
$ |
7,757 |
|
|
$ |
8,300 |
|
|
|
|
|
|
|
|
|
Costs and operating (income) expenses: |
|
|
|
|
|
|
|
Cost of products sold |
|
9,697 |
|
|
|
7,492 |
|
|
|
16,638 |
|
|
|
14,447 |
|
Research and development |
|
7,935 |
|
|
|
9,174 |
|
|
|
15,938 |
|
|
|
18,544 |
|
Selling, general and administrative |
|
14,143 |
|
|
|
15,601 |
|
|
|
28,528 |
|
|
|
31,853 |
|
Goodwill impairment |
|
— |
|
|
|
— |
|
|
|
12,026 |
|
|
|
— |
|
Restructuring |
|
— |
|
|
|
— |
|
|
|
949 |
|
|
|
— |
|
Change in fair value of contingent consideration |
|
948 |
|
|
|
(258 |
) |
|
|
955 |
|
|
|
(1,411 |
) |
Gain on sale of business |
|
(43,575 |
) |
|
|
— |
|
|
|
(43,575 |
) |
|
|
— |
|
Total costs and operating (income) expenses |
|
(10,852 |
) |
|
|
32,009 |
|
|
|
31,459 |
|
|
|
63,433 |
|
Income (loss) from operations |
|
14,928 |
|
|
|
(27,300 |
) |
|
|
(23,702 |
) |
|
|
(55,133 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Loss on debt extinguishment |
|
(7,947 |
) |
|
|
— |
|
|
|
(7,947 |
) |
|
|
— |
|
Interest income |
|
27 |
|
|
|
29 |
|
|
|
51 |
|
|
|
69 |
|
Interest expense |
|
(1,290 |
) |
|
|
(1,456 |
) |
|
|
(2,701 |
) |
|
|
(2,844 |
) |
Total other expense, net |
|
(9,210 |
) |
|
|
(1,427 |
) |
|
|
(10,597 |
) |
|
|
(2,775 |
) |
Income (loss) before income taxes |
|
5,718 |
|
|
|
(28,727 |
) |
|
|
(34,299 |
) |
|
|
(57,908 |
) |
Income tax benefit |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net income (loss) |
$ |
5,718 |
|
|
$ |
(28,727 |
) |
|
$ |
(34,299 |
) |
|
$ |
(57,908 |
) |
|
|
|
|
|
|
|
|
Other comprehensive income (loss) |
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
18 |
|
|
|
4 |
|
|
|
(39 |
) |
|
|
10 |
|
Foreign currency translation adjustment |
|
(387 |
) |
|
|
92 |
|
|
|
(553 |
) |
|
|
(134 |
) |
Comprehensive income (loss) |
$ |
5,349 |
|
|
$ |
(28,631 |
) |
|
$ |
(34,891 |
) |
|
$ |
(58,032 |
) |
|
|
|
|
|
|
|
|
Basic net income (loss) per common share |
$ |
0.16 |
|
|
$ |
(1.02 |
) |
|
$ |
(1.22 |
) |
|
$ |
(2.06 |
) |
Diluted net income (loss) per common share |
$ |
0.16 |
|
|
$ |
(1.02 |
) |
|
$ |
(1.22 |
) |
|
$ |
(2.06 |
) |
|
|
|
|
|
|
|
|
Basic weighted average shares outstanding |
|
28,339,362 |
|
|
|
28,152,305 |
|
|
|
28,229,338 |
|
|
|
28,092,329 |
|
Diluted weighted average shares outstanding |
|
28,349,429 |
|
|
|
28,152,305 |
|
|
|
28,229,338 |
|
|
|
28,092,329 |
|
Acutus Medical,
Inc.Condensed Consolidated Statements of Cash
Flows
|
Six Months EndedJune 30, |
(in thousands) |
|
2022 |
|
|
|
2021 |
|
|
|
|
(unaudited) |
Cash flows from operating activities |
|
|
|
Net loss |
$ |
(34,299 |
) |
|
$ |
(57,908 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation expense |
|
3,145 |
|
|
|
2,747 |
|
AcQMap Systems converted to sales |
|
110 |
|
|
|
— |
|
Sales-type lease gain |
|
(57 |
) |
|
|
— |
|
Amortization of intangible assets |
|
320 |
|
|
|
320 |
|
Stock-based compensation expense |
|
5,613 |
|
|
|
6,686 |
|
Amortization of premiums and accretion of discounts on marketable
securities, net |
|
264 |
|
|
|
797 |
|
Amortization of debt issuance costs |
|
641 |
|
|
|
672 |
|
Amortization of right-of-use assets |
|
321 |
|
|
|
343 |
|
Goodwill impairment |
|
12,026 |
|
|
|
— |
|
Loss on debt extinguishment |
|
7,947 |
|
|
|
— |
|
Gain on sale of business |
|
(43,575 |
) |
|
|
— |
|
Change in fair value of contingent consideration |
|
955 |
|
|
|
(1,411 |
) |
Changes in operating assets and liabilities: |
|
|
|
Accounts receivable |
|
1,037 |
|
|
|
(1,199 |
) |
Inventory |
|
1,101 |
|
|
|
(1,705 |
) |
Prepaid expenses and other current assets |
|
(3,592 |
) |
|
|
2,501 |
|
Other assets |
|
223 |
|
|
|
(289 |
) |
Accounts payable |
|
236 |
|
|
|
(2,727 |
) |
Accrued liabilities |
|
(386 |
) |
|
|
1,600 |
|
Operating lease liabilities |
|
(203 |
) |
|
|
(342 |
) |
Other long-term liabilities |
|
(45 |
) |
|
|
— |
|
Net cash used in operating activities |
|
(48,218 |
) |
|
|
(49,915 |
) |
|
|
|
|
Cash flows from investing activities |
|
|
|
Proceeds from sale of business |
|
50,000 |
|
|
|
— |
|
Direct costs paid related to sale of business |
|
(2,488 |
) |
|
|
— |
|
Purchases of available-for-sale marketable securities |
|
— |
|
|
|
(9,134 |
) |
Sales of available-for-sale marketable securities |
|
13,099 |
|
|
|
4,590 |
|
Maturities of available-for-sale marketable securities |
|
27,787 |
|
|
|
44,407 |
|
Purchases of property and equipment |
|
(1,718 |
) |
|
|
(5,841 |
) |
Net cash provided by investing activities |
|
86,680 |
|
|
|
34,022 |
|
|
|
|
|
Cash flows from financing activities |
|
|
|
Repayment of debt |
|
(44,550 |
) |
|
|
— |
|
Penalty fees paid for early prepayment of debt |
|
(1,074 |
) |
|
|
— |
|
Borrowing under new debt |
|
35,000 |
|
|
|
— |
|
Payment of debt issuance costs |
|
(624 |
) |
|
|
— |
|
Payment of deferred offering costs |
|
— |
|
|
|
(10 |
) |
Payment of contingent consideration |
|
(598 |
) |
|
|
(2,758 |
) |
Repurchase of common shares to pay employee withholding taxes |
|
(45 |
) |
|
|
— |
|
Proceeds from stock options exercises |
|
66 |
|
|
|
619 |
|
Proceeds from employee stock purchase plan |
|
182 |
|
|
|
— |
|
Net cash used in financing activities |
|
(11,643 |
) |
|
|
(2,149 |
) |
Effect of exchange rate changes on cash, cash equivalents and
restricted cash |
|
(323 |
) |
|
|
(65 |
) |
Net change in cash, cash equivalents and restricted cash |
|
26,496 |
|
|
|
(18,107 |
) |
Cash, cash equivalents and restricted cash, at the beginning of the
period |
|
24,221 |
|
|
|
25,384 |
|
Cash, cash equivalents and restricted cash, at the end of
the period |
$ |
50,717 |
|
|
$ |
7,277 |
|
Acutus Medical,
Inc.Reconciliation of GAAP Results
to Non-GAAP Results(Unaudited)
Three Months Ended June 30, 2022 |
Cost of products sold |
|
Research and development |
|
Selling, general and administrative |
|
Income (loss) from operations |
|
Other expenses, net |
|
Net income (loss) |
|
Net income allocated to common stockholders |
|
Basic and diluted EPS |
Reported |
$ |
9,697 |
|
|
$ |
7,935 |
|
|
$ |
14,143 |
|
|
$ |
14,928 |
|
|
$ |
(9,210 |
) |
|
$ |
5,718 |
|
|
$ |
4,521 |
|
|
$ |
0.16 |
|
Amortization of acquired intangibles |
|
(155 |
) |
|
|
— |
|
|
|
(5 |
) |
|
|
160 |
|
|
|
— |
|
|
|
160 |
|
|
|
160 |
|
|
|
0.01 |
|
Stock-based compensation |
|
(225 |
) |
|
|
(554 |
) |
|
|
(1,802 |
) |
|
|
2,581 |
|
|
|
— |
|
|
|
2,581 |
|
|
|
2,581 |
|
|
|
0.09 |
|
Change in fair value of contingent consideration |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
948 |
|
|
|
— |
|
|
|
948 |
|
|
|
948 |
|
|
|
0.03 |
|
Gain on sale of business |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(43,575 |
) |
|
|
— |
|
|
|
(43,575 |
) |
|
|
(43,575 |
) |
|
|
(1.54 |
) |
Loss on debt extinguishment |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
7,947 |
|
|
|
7,947 |
|
|
|
7,947 |
|
|
|
0.28 |
|
Net income allocated to participating securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,197 |
|
|
|
0.04 |
|
Adjusted |
$ |
9,317 |
|
|
$ |
7,381 |
|
|
$ |
12,336 |
|
|
$ |
(24,958 |
) |
|
$ |
(1,263 |
) |
|
$ |
(26,221 |
) |
|
$ |
(26,221 |
) |
|
$ |
(0.93 |
) |
Three Months Ended June 30, 2021 |
Cost of products sold |
|
Research and development |
|
Selling, general and administrative |
|
Loss from operations |
|
Other expenses, net |
|
Net loss |
|
Basic and diluted EPS |
Reported |
$ |
7,492 |
|
|
$ |
9,174 |
|
|
$ |
15,601 |
|
|
$ |
(27,300 |
) |
|
$ |
(1,427 |
) |
|
$ |
(28,727 |
) |
|
$ |
(1.02 |
) |
Amortization of acquired intangibles |
|
— |
|
|
|
— |
|
|
|
(160 |
) |
|
|
160 |
|
|
|
— |
|
|
|
160 |
|
|
|
0.01 |
|
Stock-based compensation |
|
(223 |
) |
|
|
(629 |
) |
|
|
(2,924 |
) |
|
|
3,776 |
|
|
|
— |
|
|
|
3,776 |
|
|
|
0.13 |
|
Change in fair value of contingent consideration |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(258 |
) |
|
|
— |
|
|
|
(258 |
) |
|
|
(0.01 |
) |
Adjusted |
$ |
7,269 |
|
|
$ |
8,545 |
|
|
$ |
12,517 |
|
|
$ |
(23,622 |
) |
|
$ |
(1,427 |
) |
|
$ |
(25,049 |
) |
|
$ |
(0.89 |
) |
Acutus Medical, Inc.Key
Business Metrics
Installed Base & Procedure
Volumes
Our total installed base as of June 30, 2022 and
2021 are set forth in the table below:
|
|
June 30, |
|
|
2022 |
|
2021 |
|
|
|
Key Business Metrics |
|
(unaudited) |
Installed base(1) |
|
75 |
|
70 |
|
|
|
|
|
(1) Installed base includes AcQMap Systems.
Our total procedure volumes for the three and six
months ended June 30, 2022 and 2021 is set forth in the table
below:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
Key Business Metrics |
(unaudited) |
|
(unaudited) |
Procedure volumes |
481 |
|
401 |
|
948 |
|
768 |
Revenue
The following table sets forth the Company’s
revenue for disposables, systems and service/other for the three
and six months ended June 30, 2022 and 2021 (in thousands):
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
(unaudited) |
|
(unaudited) |
Disposables |
$ |
3,334 |
|
$ |
3,509 |
|
$ |
6,545 |
|
$ |
5,852 |
Systems |
|
346 |
|
|
799 |
|
|
346 |
|
|
1,768 |
Service/Other |
|
396 |
|
|
401 |
|
|
866 |
|
|
680 |
Total revenue |
$ |
4,076 |
|
$ |
4,709 |
|
$ |
7,757 |
|
$ |
8,300 |
The following table provides revenue by geographic
location for the three and six months ended June 30, 2022 and 2021
(in thousands):
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
(unaudited) |
|
(unaudited) |
United States |
$ |
2,037 |
|
$ |
2,486 |
|
$ |
4,060 |
|
$ |
4,068 |
Outside the United States |
|
2,039 |
|
|
2,223 |
|
|
3,697 |
|
|
4,232 |
Total revenue |
$ |
4,076 |
|
$ |
4,709 |
|
$ |
7,757 |
|
$ |
8,300 |
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